Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | VASOSEAL ELITE VHD/ES DEVICE |
Generic Name | Device, hemostasis, vascular |
Applicant | St. Jude Medical, Inc. 177 E.COUNTY RD. B EAST ST PAUL, MN 55117 |
PMA Number | P920004 |
Supplement Number | S018 |
Date Received | 03/26/2002 |
Decision Date | 08/13/2002 |
Withdrawal Date
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12/06/2013 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF A SINGLE SPONGE COLLAGEN PLUG. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ELITE VHD OR ES DEVICE AND IS INDICATED FOR: "SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS, AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES. IN ADDITION, THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO DISCHARGE IN DIAGNOSTIC PATIENTS RECEIVING 5-6 FRENCH PROCEDURAL SHEATHS. VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS IN INTERVENTIONAL, PATIENTS, WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED." THE VASOSEAL ELITE VHD DEVICE INDICATIONS INCLUDE THE STATEMENT: "HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DETERMINED." |
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